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Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot

Primary Purpose

Flat Foot; Rigid, Flat Foot; Spastic

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Joint Preserving Surgery in spasmodic flat foot
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Flat Foot; Rigid

Eligibility Criteria

14 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Painful, incorrectable pes Plano valgus after failure of conservative treatment
  • Age: patients with skeletally mature foot as proved by x-ray

Exclusion Criteria:

  • coalition bar
  • Ankle subtalar joint arthritis.
  • Previous foot fractures.
  • Severe trophic skin disorders
  • Standard contraindications to any surgery such as poor circulation, concurrent infection, other co-morbidity".

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    spasmodic flat foot

    Arm Description

    extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot

    Outcomes

    Primary Outcome Measures

    assess the foot deformity
    assess foot deformity : full correction (valgus<10 degree), partial correction(valgus<15 degree),valgus >15 degree)
    assess the pain: Visual Analog Score
    The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. This tool was first used in psychology by Freyd in 1923

    Secondary Outcome Measures

    Full Information

    First Posted
    December 30, 2018
    Last Updated
    March 17, 2019
    Sponsor
    Assiut University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03880318
    Brief Title
    Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
    Official Title
    Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2019
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 1, 2019 (Anticipated)
    Primary Completion Date
    March 2020 (Anticipated)
    Study Completion Date
    April 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Assiut University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    the investigators want to obtain a functional and radiological outcome of peroneus brevis, tertius and extensor digitorum longus muscles lengthening together with calcaneal osteotomies in the treatment of the spasmodic flat- foot.
    Detailed Description
    One of the most common foot complaints is the "flatfoot" deformity. Clinical evaluation of flatfeet primarily focuses on differentiation between the two main types: flexible and rigid. The rigid flatfoot deformity is an uncommon diagnosis (occurring one-third as often as the flexible type) but often is symptomatic and requires treatment". Multiple causes of rigid flatfeet have been identified such as rheumatoid arthritis, tarsal coalitions (being the most common cause) that are excluded from that research. Triple arthrodesis is used for treatment of rigid flat foot but the patient satisfaction is not good as there is some stiffness in the foot .but here the investigators want to know what is the effect of extensor digitorum longus, peroneus brevis and tertius lengthening together with osteotomies in alignment of spasmodic flat- foot. In patient with rigid flat- foot or spasmodic flat- foot will often have the hind-foot alignment to the outside. Alignment of the heel influences how weight-bearing stress is applied to the foot, ankle, knee and hip. So, these patients may benefit from the calcaneal osteotomies and extensor digitorum longus, peroneus brevis and tertius lengthening to improve that alignment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Flat Foot; Rigid, Flat Foot; Spastic

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    22 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    spasmodic flat foot
    Arm Type
    Other
    Arm Description
    extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies in spasmodic flat foot
    Intervention Type
    Procedure
    Intervention Name(s)
    Joint Preserving Surgery in spasmodic flat foot
    Intervention Description
    extensor digitorum longus, peroneus brevis and tertius lengthening together with calcaneal osteotomies
    Primary Outcome Measure Information:
    Title
    assess the foot deformity
    Description
    assess foot deformity : full correction (valgus<10 degree), partial correction(valgus<15 degree),valgus >15 degree)
    Time Frame
    Baseline
    Title
    assess the pain: Visual Analog Score
    Description
    The Visual Analogue Scale (VAS) consists of a straight line with the endpoints defining extreme limits such as 'no pain at all' and 'pain as bad as it could be'. The patient is asked to mark his pain level on the line between the two endpoints. The distance between 'no pain at all' and the mark then defines the subject's pain. This tool was first used in psychology by Freyd in 1923
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Painful, incorrectable pes Plano valgus after failure of conservative treatment Age: patients with skeletally mature foot as proved by x-ray Exclusion Criteria: coalition bar Ankle subtalar joint arthritis. Previous foot fractures. Severe trophic skin disorders Standard contraindications to any surgery such as poor circulation, concurrent infection, other co-morbidity".

    12. IPD Sharing Statement

    Learn more about this trial

    Joint Preserving Surgery for Correction of Spasmodic Flat- Foot in Skeletally Mature Foot

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